【摘要】：背景:臨床試驗(yàn)是驗(yàn)證新藥(包括器械及體外診斷試劑等)的有效性和安全性必不可少的步驟,而通常臨床試驗(yàn)及其預(yù)實(shí)驗(yàn)是一個周期相對較長且花費(fèi)較高的過程,這是因?yàn)閭鹘y(tǒng)的臨床試驗(yàn)會使用紙質(zhì)的病例報告表來記錄和收集受試者的臨床試驗(yàn)數(shù)據(jù),數(shù)據(jù)管理人員不僅需要對紙質(zhì)的數(shù)據(jù)進(jìn)行雙盲錄入,還需要在錄入過程中不斷地和試驗(yàn)中心的人員進(jìn)行溝通以完成數(shù)據(jù)正確性和完整性的核查。所以紙質(zhì)病例報告表這一形式往往會造成數(shù)據(jù)錄入及其后續(xù)統(tǒng)計分析的滯后,而且數(shù)據(jù)的有效性、正確性和完整性也往往得不到有效地保證,這會大大增加整個試驗(yàn)的周期和開支。隨著互聯(lián)網(wǎng)信息技術(shù)的發(fā)展,EDC(Electronic Data Capture)系統(tǒng)在臨床試驗(yàn)中的使用不僅提高了數(shù)據(jù)收集的質(zhì)量,還節(jié)省了試驗(yàn)進(jìn)行所需的成本和開銷,最終縮短了臨床試驗(yàn)的進(jìn)行周期。目的:本文旨在為開發(fā)一款EDC系統(tǒng)提出構(gòu)建的思路與策略,該系統(tǒng)基于Web實(shí)現(xiàn),且具有試驗(yàn)設(shè)計、數(shù)據(jù)錄入、核查、質(zhì)疑管理、稽查留痕、電子簽名與用戶權(quán)限管理等常用功能,并符合具體法規(guī)和行業(yè)標(biāo)準(zhǔn)。本文針對其中的一些難點(diǎn)和關(guān)鍵點(diǎn)加以說明和討論,特別是用戶角色權(quán)限控制、實(shí)驗(yàn)設(shè)計中的eCRF構(gòu)建及其數(shù)據(jù)庫設(shè)計等方面,都是EDC系統(tǒng)開發(fā)中一定會面臨的難點(diǎn)和挑戰(zhàn)。方法:我們在文章第一部分首先整理并介紹了 EDC系統(tǒng)構(gòu)建時所需的一些主要的信息化技術(shù),如用作訪問請求回應(yīng)的網(wǎng)頁服務(wù)器、用作動態(tài)響應(yīng)及邏輯處理的服務(wù)器端腳本、儲存數(shù)據(jù)的數(shù)據(jù)庫服務(wù)、數(shù)據(jù)傳遞標(biāo)準(zhǔn)化和eCRF視圖儲存的XML技術(shù)、用于提供良好的用戶交互的前端界面設(shè)計、以及臨床試驗(yàn)必不可少的數(shù)據(jù)安全與備份技術(shù)等方面;然后在第二部分中根據(jù)不同功能的具體需求,并結(jié)合相關(guān)法規(guī)(如我國的國家食品藥品監(jiān)督管理總局(CFDA)發(fā)布的臨床試驗(yàn)的電子數(shù)據(jù)采集技術(shù)指導(dǎo)原則、美國的FDA的21 CFR Part11法令等)和行業(yè)標(biāo)準(zhǔn)(如CDISC等),為EDC系統(tǒng)的構(gòu)建提出了相應(yīng)的策略和實(shí)施辦法。結(jié)論:EDC系統(tǒng)是一個典型的信息化系統(tǒng),因此整個過程不能一蹴而就,要在對每一個具體功能都進(jìn)行了精準(zhǔn)分析的前提下,對需求的各個方面都做到有效耦合關(guān)聯(lián)的情況下,才能開發(fā)出一套合規(guī)的、完整的、用戶友善的EDC系統(tǒng)。因此,在EDC系統(tǒng)的實(shí)際開發(fā)中,除了要考慮本文提到的這些信息化技術(shù)的應(yīng)用和具體法規(guī)要求而外,還需要考慮諸如用戶需求溝通、系統(tǒng)開發(fā)周期、系統(tǒng)安裝實(shí)測以及綜合成本等各項(xiàng)因素。
[Abstract]:Background: clinical trials are essential steps to verify the efficacy and safety of new drugs, including instruments and in vitro diagnostic reagents, while clinical trials and their pretrials are usually a relatively long and costly process. This is because traditional clinical trials use paper case reports to record and collect clinical trial data, and data managers not only have to do double-blind input of paper data. There is also a need for continuous communication with test center personnel during the entry process to complete data correctness and completeness verification. Therefore, the form of paper case report forms often leads to the lag of data entry and subsequent statistical analysis, and the validity, correctness and completeness of the data are often not effectively guaranteed. This will greatly increase the cycle and cost of the experiment. With the development of Internet information technology, the use of, EDC (Electronic Data Capture) system in clinical trials not only improves the quality of data collection, but also saves the cost and expense of the trials, and finally shortens the cycle of clinical trials. Objective: the purpose of this paper is to develop a EDC system based on Web, which is based on Web, and has experimental design, data entry, verification, query management, check marks. Electronic signature and user rights management and other common functions, and comply with specific regulations and industry standards. In this paper, some difficulties and key points are explained and discussed, especially the user role privilege control, eCRF construction and database design in experimental design, all of which are the difficulties and challenges in the development of EDC system. Methods: in the first part of the article, we first organize and introduce some of the main information technologies needed to build the EDC system, such as the web server used for accessing request response, the server-side script for dynamic response and logic processing. Database service for storing data, XML technology for data transfer standardization and eCRF view storage, used to provide good user interaction front-end interface design, as well as necessary data security and backup technology for clinical trials, etc. Then in the second part, according to the specific needs of different functions, and combining the relevant laws and regulations (such as the (CFDA) issued by the State Administration of Food and Drug Administration of China, the guidelines of electronic data acquisition technology for clinical trials, The 21 CFR Part11 Act of FDA and the industry standard (such as CDISC etc.) in the United States put forward the corresponding strategies and implementation methods for the construction of EDC system. Conclusion: EDC system is a typical information system, so the whole process can not be accomplished overnight. To develop a compliant, complete, user-friendly EDC system. Therefore, in the actual development of EDC system, in addition to the application of these information technology mentioned in this paper and the specific requirements of laws and regulations, we also need to consider such as user needs communication, system development cycle, System installation test and comprehensive cost and other factors.
【學(xué)位授予單位】：南方醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R95

【參考文獻(xiàn)】

相關(guān)期刊論文 前5條

1 郭韶潔;趙秀麗;周輝;;臨床試驗(yàn)中不良事件管理的問題及分析[J];中國臨床藥理學(xué)雜志;2014年01期

2 陸芳;高蕊;唐旭東;李睿;;臨床研究中的數(shù)據(jù)管理標(biāo)準(zhǔn)CDISC及其應(yīng)用前景[J];中國新藥雜志;2011年24期

3 蔣志偉;夏結(jié)來;李嬋娟;王陵;張春茂;;基于結(jié)構(gòu)化病例報告表的EDC構(gòu)建策略[J];中國新藥雜志;2009年23期

4 卜擎燕;熊寧寧;鄒建東;蔣萌;劉芳;Anna Zhao-Wong;;ICH國際醫(yī)學(xué)用語詞典(MedDRA):藥事管理的標(biāo)準(zhǔn)醫(yī)學(xué)術(shù)語集[J];中國臨床藥理學(xué)與治療學(xué);2007年05期

5 林磊,駱建彬,鄧憲,宋志剛;管理信息系統(tǒng)中基于角色的權(quán)限控制[J];計算機(jī)應(yīng)用研究;2002年06期

，

本文編號：2315494